Care Bundle for Stroke

(I-CATCHER Trial)

Recruiting at 15 trial locations

Overseen By Trine Apostolaki-Hansson, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Region Skane

Disqualifiers: Previous care limitation, End-stage comorbidity, Brain tumor, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

3500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a structured treatment package, called a Care Bundle, can improve recovery for individuals who have experienced a spontaneous intracerebral hemorrhage (a type of stroke caused by brain bleeding). The trial compares the Care Bundle, which includes rapid treatment of high blood pressure, fever, and high blood sugar, to standard care. Participants will receive either the International Care Bundle or the usual hospital care. Individuals who have had a stroke caused by brain bleeding within the last 24 hours, confirmed by a CT scan, may be suitable for this trial. The study aims to determine if this approach can lead to better outcomes three months after the stroke. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved treatment can benefit more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for the International Care Bundle?

Research has shown that the International Care Bundle is safe and well-tolerated for patients with intracerebral hemorrhage (ICH). In earlier studies, this care bundle significantly reduced negative outcomes. Specifically, one study reported a 5.6% decrease in poor recovery results, indicating better patient recovery. Another study found a 33% reduction in deaths within 30 days, with the rate dropping from 35.5% to 24.2%.

These findings suggest that the care bundle is both effective and safe for patients with ICH. No major reports of harmful effects have emerged, making it a reassuring option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Care Bundle for Stroke because it offers a proactive approach to stroke management by implementing a structured protocol with time- and target-based metrics. Unlike the usual care, which relies on individual clinical team decisions, this care bundle aims for rapid correction of abnormal physiological variables and structured referral pathways, potentially leading to quicker and more consistent patient outcomes. This method emphasizes speed and precision, which could significantly improve recovery times and reduce complications compared to standard practices.

What evidence suggests that the International Care Bundle is effective for improving prognosis in patients with spontaneous intracerebral haemorrhage?

The current trial will compare the International Care Bundle with usual care for patients with spontaneous intracerebral hemorrhage (ICH). Studies have shown that the International Care Bundle can enhance recovery by improving patients' ability to perform everyday activities after a stroke. This treatment package focuses on quickly managing factors such as blood pressure, fever, and blood sugar levels. By addressing these issues early, the treatment aims to reduce brain damage and improve recovery chances. This approach has already demonstrated promise in hospitals, leading to better recovery rates and potentially saving lives. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals who've had a stroke caused by cerebral hemorrhage within the last 24 hours, confirmed by CT scan. It's not suitable for those with other types of strokes or conditions that might interfere with the treatment.

Inclusion Criteria

My brain bleed was confirmed by a CT scan without dye.

My symptoms started less than 24 hours ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Phase 1: Usual Care

Hospitals provide usual care to patients with ICH as part of the baseline period

6 months

Phase 2: Randomized Evaluation

Hospitals are randomized to either implement the Care Bundle or continue with usual care

6 months

Phase 3: Post-implementation Follow-up

All hospitals implement the Care Bundle and are monitored for sustainability and integration into routine practice

6 months

Follow-up

Participants are monitored for functional outcomes and quality of life after the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• International Care Bundle

Trial Overview The study tests a 'Care Bundle' including early blood pressure control, fever and high blood sugar management, neurosurgery referral if needed, and rapid reversal of oral anticoagulation against standard care to improve outcomes after cerebral hemorrhage.

How Is the Trial Designed?

Group I: Intervention group Active Control 8 Interventions

A range of implementation methods will be used to introduce an active Care Bundle with time- and target-based metrics that involve the rapid correction of abnormal physiological variables over days or hospital discharge (or death, if sooner) and referral pathways

Group II: Usual care Placebo Group 1 Intervention

For patients in the usual-care group, decisions about the location of care delivery, investigations, monitoring, and all treatments are made by the treating clinical team. Data will be collected regarding the management of patients, including insertion of invasive monitoring devices, intravenous fluid resuscitation, BP lowering, vasoactive support, glycemic control, mechanical ventilation, neurosurgery, and other supportive therapy.

Who Is Running the Clinical Trial?

Region Skane

Lead Sponsor

Trials

369

Recruited

599,000+

The George Institute for Global Health, Australia

Collaborator

Trials

20

Recruited

50,200+

Ottawa Hospital Research Institute

Collaborator

Trials

585

Recruited

3,283,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40356012/?utm_source=SimplePie&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1xgjY15FSEnM08BkUJAPtKRrCbdCxnt6lonHr5p3-CWMNYSszy&fc=20220523101529&ff=20250513034644&v=2.18.0.post9+e462414

Study protocol for a multicenter, batched, parallel, cluster- ... An international collaborative initiative aimed at determining whether implementation of a care bundle improves functional outcome for patients with ICH in HIC.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06429332

Study Details | NCT06429332 | International Care Bundle ... The purpose of I-CATCHER is to investigate whether a structured treatment package (Care Bundle) improves 3-month prognosis in patients with spontaneous ICH ...

3. thelancet.com thelancet.com/article/S0140-6736(23)00806-1/fulltext

The third Intensive Care Bundle with Blood Pressure ... The primary result was that the implementation of the care bundle across participating hospitals resulted in patients having a better functional outcome ( ...

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/17474930251342888

Study protocol for a multicenter, batched, parallel, cluster- ... The primary outcome is UW-mRS at 6 months. Secondary outcomes include death, functional status, and health-related quality of life.

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1357815/full

Influence of bundled care treatment on functional outcome ... The present study investigated whether the consistent and effective implementation of bundled care treatment (BCT) targets for systolic blood ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12264302/

International Care Bundle Evaluation in Cerebral Hemorrhage ... An international collaborative initiative aimed at determining whether implementation of a care bundle improves functional outcome for patients with ICH in HIC.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11318433/

Acute care bundles should be used for patients with ... The bundle was associated with a reduction in 30-day case fatality of over 33% (from 35.5% to 24.2%) in a before and after study. The QASC trial ...

8. neurology.org neurology.org/doi/10.1212/WNL.0000000000214070

Mediation Analysis to Identify Individual Component Effects ... We performed a model-based causal mediation analysis to assess the contribution of each component of the care bundle to the overall effect, as ...